Effect of Bilateral Distalization of Upper First Molars in a Group of Patients After Extraction of Maxillary Second Molars

Sponsor

Future University in Egypt (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05592977

Collaborator

(none)

Enrollment

Location

Arm

24.7

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

There is a scarcity in the current literature regarding such appliance and its effect on distalizing the first maxillary molar in absence of the second molar. Therefore, this study was made to evaluate the effect of bilateral distalization of upper first molars in a group of patients after extraction of maxillary second Molars using infra zygomatic mini implants.

Condition or Disease	Intervention/Treatment	Phase
Class II Malocclusion	Device: Intra-Oral Distalizing Device	N/A

Detailed Description

The appliances available for distalization used to be mainly extraoral distalizing appliances which depended entirely on patient cooperation and compliance. Even after the emergence of intra-oral distalizing appliances they had adverse dentoalveolar effect such as anchorage loss and flaring of the upper anterior teeth. Thus, this study was made in order to evaluate the efficiency of our proposed appliance in the treatment of Class II patients while avoiding the adverse effects mentioned above.

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Masking Description:

Due to the nature of the study, the operator and patients can't be blinded. Blinding of the outcome assessors can be done by sealing the name of the patient in the pre and post treatment radiographs used for analysis

Primary Purpose:

Treatment

Official Title:

Effect of Bilateral Distalization of Upper First Molars in a Group of Patients After Extraction of Maxillary Second Molars Using Infra Zygomatic Mini Implants: A Prospective Clinical Trial

Actual Study Start Date :

Nov 9, 2020

Actual Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intra-oral Distalizing Appliance Two infra zygomatic mini-implants will be placed Bands will be cemented to upper first molars. The inner bow (1.2mm) is a modified version of the inner part of a conventional face bow. Two hooks were soldered onto the inner bow distal to the lateral incisor teeth regions, and U loop at 1st premolar region, and bends acting as mesial stop will be bent in front of the maxillary first molars. Orthodontic force 300 mg per side Will be delivered by Niti closed coil spring which is attached from infra zygomatic mini screw to the hook soldered to the wire framework.	Device: Intra-Oral Distalizing Device The inner bow (1.2mm) is a modified version of the inner part of a conventional face bow. Two hooks were soldered onto the inner bow distal to the lateral incisor teeth regions, and U loop at 1st premolar region, and bends acting as mesial stop will be bent in front of the maxillary first molars. The anterior component of the inner bow is 3 mm free from the labial surface of anterior teeth

Arm

Intervention/Treatment

Experimental: Intra-oral Distalizing Appliance

Two infra zygomatic mini-implants will be placed Bands will be cemented to upper first molars. The inner bow (1.2mm) is a modified version of the inner part of a conventional face bow. Two hooks were soldered onto the inner bow distal to the lateral incisor teeth regions, and U loop at 1st premolar region, and bends acting as mesial stop will be bent in front of the maxillary first molars. Orthodontic force 300 mg per side Will be delivered by Niti closed coil spring which is attached from infra zygomatic mini screw to the hook soldered to the wire framework.

Device: Intra-Oral Distalizing Device

The inner bow (1.2mm) is a modified version of the inner part of a conventional face bow. Two hooks were soldered onto the inner bow distal to the lateral incisor teeth regions, and U loop at 1st premolar region, and bends acting as mesial stop will be bent in front of the maxillary first molars. The anterior component of the inner bow is 3 mm free from the labial surface of anterior teeth

Outcome Measures

Primary Outcome Measures

linear distalization of maxillary 1st molar. [Up until Class I Molar Relation (a maximum of 8 months regardless)]
Efficiency of the proposed appliance to induce distalization of the upper 1st molar measured on Scanned dental casts as well as cone-beam computed tomography (CBCT) in millimetres.
Rate of maxillary 1st molar Distalization in mm/ month. [Up until Class I Molar Relation (a maximum of 8 months regardless)]
Efficiency of the proposed appliance to induce distalization of the upper 1st molar measured on Scanned dental casts with a monthly follow up in millimetres.

Secondary Outcome Measures

Changes in Intermolar width in mm. [Up until Class I Molar Relation (a maximum of 8 months regardless)]
Effect of the proposed appliance on the transverse Dental changes in the upper buccal segment through scanned dental cast in millimetres
Changes of Molar inclination in degrees. [Up until Class I Molar Relation (a maximum of 8 months regardless)]
Effect of the proposed appliance on the angulation of the first permanent molar through scanned dental cast and cone-beam computed tomography (CBCT) in degrees.

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Female Patients with cervical vertebra maturation index (CVMI) 5 & 6.
From quarter unit to 3\4-unit class II molar relationship.
An overjet of an average 6mm.
Full Set of permanent dentition except for the maxillary second molar.
Favorable path of eruption for the maxillary third molar.

Exclusion Criteria:

Medically compromised Patients.
Patients under long term medications.
Patients having sever periodontal disease.
CVMI 3 or less
Full unit class II cases

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Future University In Egypt	New Cairo	Cairo	Egypt	11835

Sponsors and Collaborators

Future University in Egypt

Investigators

Study Director: Yehia Mostafa, Professr and Chairman, Future University in Egypt

Study Documents (Full-Text)

More Information

Publications

None provided.

Responsible Party:

Hosam Abdullah Mohamed Zaza, Principle investigator, Future University in Egypt

ClinicalTrials.gov Identifier:

NCT05592977

Other Study ID Numbers:

FUE.REC(23)/11-2020

First Posted:

Oct 25, 2022

Last Update Posted:

Nov 30, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hosam Abdullah Mohamed Zaza, Principle investigator, Future University in Egypt

Intermolar Width

Molar Inclination

Intra-oral Appliance

Infrazygomatic Mini-screws

Distalization

Additional relevant MeSH terms:

Malocclusion

Malocclusion, Angle Class II

Overbite

Study Results

No Results Posted as of Nov 30, 2022